Acupuncture or Metformin for Insulin Resistance in Women With PCOS

Brief description of study

The hypothesis is that acupuncture is equally effective as metformin (both treatments
combined with lifestyle management) in improving whole body glucose homeostasis in insulin
resistant women with polycystic ovary syndrome (PCOS), and that both are superior to
lifestyle management alone. The investigators hypothesize that acupuncture and metformin
induce ovulation and improve hyperandrogenism, as well as health related quality of life
(HRQoL) and symptoms of anxiety and depression. Although equally effective (acupuncture and
metformin), the investigators hypothesize that acupuncture is associated with less negative
side-effects. The investigators also hypothesize that these treatments have the potential to
restore epigenetic and molecular alterations in target tissues (endometrial-, adipose-, and
skeletal muscle tissue) and thus have the potential to prevent the development of type 2
diabetes (T2D).

Detailed Study Description

Specific Aims The purpose of the study is to perform a randomized controlled trial of women
with PCOS, comparing the effectiveness of lifestyle management alone, and in combination with
acupuncture or metformin treatment on whole body glucose homeostasis, with the ultimate goal
to prevent the development of type 2 diabetes.

Primary aim

To determine the clinical effectiveness of 4 months of 1) electroacupuncture + lifestyle
management and 2) metformin + lifestyle management, compared to 3) lifestyle management only,
for improvement of insulin sensitivity as measured by HOMA-IR, by the insulin response to
glucose assessed by calculating the area under the curve (AUCinsulin) during the oral glucose
tolerance test (OGTT), and by glucose regulation (assessed by analyzing Hba1c levels).

Secondary aims

To evaluate changes in secondary metabolic measures, including fasting insulin,
c-peptide, glucose, and adipokines, calculation of HOMA-B (i.e. the Islet -cell
function) and the c-peptide index, assessment of the adipokines and lipid profile, body
size and proportions and body fat distribution.